earlens Light Operating instructions

Brand: earlens

Model: Light

Type: Operating instructions

Earlens Light, your new hearing aid, uses non-visible light to send sound information directly to your eardrum. It's custom-made for you, providing a full spectrum of amplification from 125 Hz to 10,000 Hz. With its open-fit design, you'll experience natural sound quality without the feeling of occlusion. Enjoy wireless connectivity to your smartphone or tablet for added convenience and control. If you have any discomfort or questions, consult your hearing professional. Welcome to a new world of hearing with Earlens Light!

IFU00021vP

12/19/19

1. Introduction ................................................................................................................................. 2

2. Wireless Earlens Light-Driven Hearing Aid Device Description ........................... 2

3. Indications for Use ................................................................................................................... 3

4. Fitting Range ............................................................................................................................... 3

5. Contraindications ..................................................................................................................... 3

6. Warnings ....................................................................................................................................... 4

7. Precautions.................................................................................................................................. 4

8. Clinical Study Results ............................................................................................................. 5

9. Operating Instructions ............................................................................................................ 7

10. Operating Specifications ....................................................................................................... 9

11. Glossary of Terms .................................................................................................................. 10

12. Graphic Symbols Contained in Device Labeling ....................................................... 10

13. Laser Certification .................................................................................................................. 11

Wireless Earlens Light-Driven Hearing Aid Physician Instructions

IFU00021vP

12/19/19

1. Introduction

CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE.

Rx ONLY

For patient instructions, please see Earlens Light-Driven Hearing Aid Patient Instructions. For hearing

professional instructions, please see Earlens Light-Driven Hearing Aid Hearing Professional Instructions.

2. Wireless Earlens Light-Driven Hearing Aid Device Description

The wireless Earlens Light-Driven Hearing Aid uses non-visible light

to send sound information to a customized Tympanic Lens (Lens).

The Lens converts the light into vibrations that are directly applied to

the eardrum and are perceived as sound (Figure 1). The Earlens

Hearing Aid System includes the following:

• Lens

• Photon™ 2 Processor

• Light Tip

• Earlens Fitting Software (ELF)

• Charger with Power Adapter

• Earlens Impression System

• Mineral Oil

• Earlens Control Mobile Application

2.1. Tympanic Lens

The Lens (Figure 2) is designed to receive light signals from the

Light Tip and convert the light signals into mechanical vibrations

of the tympanic membrane (TM). The Lens is customized for

each patient and is placed in to position by a trained physician. It

is placed at the end of the ear canal on the skin around the TM.

2.2. Photon™2 Processor and Light Tip

The Processor is directly connected to the Light Tip via the cable

(Figure 3). The Processor is designed to pick-up sounds via the

microphones, apply signal processing and transmit the signal via

the cable to the Light Tip. The Processor should be placed in the

Charger for recharging every day.

The Processor features a wireless antenna that allows for direct

connectivity with select smartphones and tablets. The use of this

feature is optional. Information on settings and use of the

wireless functionality can be found in the hearing professional

and patient Instructions for Use. For additional information,

please contact your Earlens support team or visit

www.earlens.com/connectivity.

The Light Tip is connected to the Processor via the cable and

can be physically modified by a hearing professional to improve

fit. The Light Tip shell features a large opening or vent, which is

designed to allow the ear canal to have an open, non-occluding

feel (Figure 4). The Light Tip is specifically designed to stabilize

and aim the emitter at the Lens.

Figure 1: Earlens component schematic

Processor

Lens

Light Tip

Figure 2: Lens

Figure 3: Processor & Light Tip

Figure 4: Light Tip large vent opening

IFU00021vP

12/19/19

2.3. Earlens Fitting Software (ELF)

ELF is used to program the Processor, enabling the hearing professional to calibrate and program the

Processor specific to the patient’s needs.

2.4. Earlens Charger and Power Adaptor

The Charger is designed to recharge the Processors

(Figure 5). When connected to the wall power

adaptor, the Charger houses and chargers either

one or two Processors simultaneously. An AC wall

power adaptor is included.

2.5. Earlens Impression System

The Earlens Impression System is used by the

physician to collect a deep ear canal impression. The

impression is used to manufacture the customized

Lens and Light Tip.

2.6. Mineral Oil

White mineral oil (food grade) is used to lubricate the

eardrum to keep the Lens in place and functioning

properly. To maintain the devices, it is recommended

that patients apply two pumps of mineral oil to their ears daily.

3. Indications for Use

The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by

vibrating the eardrum through direct contact. It is indicated for

individuals 18 years and older with a mild to severe sensorineural

hearing impairment who can benefit from amplification. The device

can provide the full spectrum of amplification that includes 125 Hz –

10,000 Hz.

4. Fitting Range

The Earlens Light Driven Hearing Aid provides the full spectrum of

amplification that includes 125 Hz – 10,000 Hz. The audiometric

fitting range for the Earlens Hearing Aid is shown in Figure 6.

5. Contraindications

The patient must not have any known or active medical issues that

would preclude having a hearing device, including:

a. an abnormal TM (deemed perforated, inflamed or has dimeric or

monomeric area, or in any other way abnormal);

b. an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes;

c. an ear canal anatomy that prevents the physician from seeing an adequate amount of the TM;

d. an anatomical configuration of the external auditory canal that

prevents satisfactory placement of the Lens;

e. a history of chronic and recurrent ear infections in the past 24 months;

f. a rapidly progressive or fluctuating hearing impairment;

g. diagnosed with having a compromised immune system which may impact the tissue of the auricle

or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or

received radiation of the head ever or chemotherapy for cancer within the last six years.

Note: Once the otologic and audiologic indications for use were met, approximately 95% of patients were

successfully fit with the Earlens Hearing Aid (5% were unable to anatomically accommodate the Lens).

Figure 5: Earlens Charger

Figure 6: Earlens Fitting Range

IFU00021vP

12/19/19

6. Warnings

Before using the Earlens Hearing Aid, make sure you read and understand each of the following

safety warnings:

• The Earlens Hearing Aid is considered MR unsafe. The Lens should be removed prior to an MRI

exam or MRI exposure. Only physicians trained in Ear, Nose & Throat procedures should

place or remove the Lens.

• The patient should not use therapeutic or medical diathermy using electromagnetic radiation

(magnetic induction coils or microwave) from the shoulders up with Earlens Hearing Aid in place.

• The Processor and Light Tip unit contain a Class 1 laser product. It is safe to

use under normal operating conditions. The Class 1 laser light is NOT visible.

Do NOT look directly into the laser or aim directly into the eyes. Should any part

of the Earlens Hearing Aid become damaged, the patient should discontinue

use and contact their hearing professional.

• If the patient experiences discomfort or pain in their ear, they should contact their ENT physician

immediately. Only physicians trained in Ear, Nose & Throat procedures should place or remove

the Lens.

• The patient should not insert foreign objects into the ear, such as Q-tips, bobby pins or

fingernails. Insertion of foreign objects could result in pain and damage to the ear, damage to the

Lens or cause it to operate improperly.

• The patient should contact their hearing professional if they experience discharge from the ear or

persistent discomfort or any other problems.

• Should the Processor become unusually warm or hot, the patient should promptly remove it,

discontinue use and contact their hearing professional.

• Do not crush, short circuit, modify or disassemble any component of the Earlens Hearing Aid.

Keep all components of the Earlens Hearing Aid out of the reach of children, pets and others, to

avoid risk of swallowing.

• Do not incinerate any component of the Earlens Hearing Aid or use near open flame. Handle

waste from electronic equipment per local regulations.

7. Precautions

Before using the Earlens Hearing Aid, make sure you and the patient read and understand each

of the following safety precautions.

• Individuals with known nickel sensitivity/allergy should be informed that the Lens component

contains nickel that is coated with a parylene barrier. If an allergic reaction develops, the Lens

should be promptly removed.

• The Lens was tested for nickel leaching and found to be compliant and within the safe levels

identified in European standard EN1811. Traces of oxidation (discoloration) may be visible on the

Lens surface following prolonged wear. Testing indicated the oxidation was not likely to affect the

structural integrity of the Lens within the 1 year expected life.

• Only hearing healthcare professionals trained in the fitting of hearing aids may fit the Earlens

Processor and Light Tip.

• The Earlens Hearing Aid is custom designed and intended to be used for a single patient.

• The Light Tip is designed to sit a set distance from the Lens. Sound output may deviate if the

Light Tip is not inserted to the proper depth. If the sound output does deviate, the patient can

reposition the Light Tip until optimal sound output is achieved.

• Earplugs or headphones can be used with the Lens in place as long as care is taken not to over-

insert them and they do not protrude deeply into the ear canal.

• The patient may shower, bathe or swim with the Lens in place. Ear plugs may be used to prevent

water from entering the ears so long as care is taken to not over-insert them. Removing water

from ears may be more difficult with the Lens in place.

Class 1 Laser

Product

IFU00021vP

12/19/19

• If the patient has small or unusually shaped ear canals, they may be at greater risk for ear canal

abrasions, either from the ear impression procedure or from Light Tip use.

• The patient should avoid getting the Processor wet, as it may damage the device. The patient

must remove the Processor prior to showering, swimming, or bathing.

• The patient may experience a reduction in their hearing levels when the Lens is in place but the

Processor is not activated.

• Do not direct streams of liquid (i.e. isopropyl alcohol, hydrogen peroxide, DeBrox) into ears, as

this may cause the Lens to become dislodged or cause damage to the device.

• Failure to oil the ear canal may result in Lens displacement.

• Do not place any component of the Earlens Hearing Aid into a microwave, or near a significant

source of static electricity.

• Use only the Earlens Charger and AC wall adapter provided. Although other adapters may look

similar, they may cause damage to the Earlens Hearing Aid.

• Handle the components carefully and prevent hard knocks. Do not drop them as it may damage

the Earlens Hearing Aid.

• If the Earlens Processor fails to operate or if it appears damaged, including the presence of

battery leakage or swelling, the patient should promptly remove the Processor, discontinue use

and contact their hearing professional.

• Only clean the Processor with a soft cloth. Do not use chemicals (i.e. hairspray) in close proximity

or to clean the Processor.

• Keep Charger cord out of reach of individuals who may be at risk of strangulation.

• Electromagnetic fields produced by other electrical equipment such as cell phones, metal

detectors, microwaves, RFID systems and commercial theft detection systems (also known as

electronic article surveillance [EAS]) may interfere with the Earlens Hearing Aid. In the event that

the patient perceives unexpected noise or interference in the presence of the Earlens Hearing

Aids, move away from the source to mitigate the potential interference. If the patient has further

concerns they should remove the Processors and contact their hearing professional.

8. Clinical Study Results

The Definitive Clinical Study of the Earlens Light Driven Hearing Aid confirmed the safety and

effectiveness of the Earlens Hearing Aid for individuals with a mild to severe sensorineural hearing

impairment between the frequencies of 125 Hz – 10,000 Hz. The prospective, single arm study assessed

48 subjects (96 ears) who wore the fully activated Earlens Hearing Aid in both ears in their daily lives for

four months per study protocol. Safety and effectiveness were assessed during the four months.

8.1. Study Demographics

The average age of the study population was 69 years with a gender ratio of 60% for males and 40% for

females. The subjects were seen across three clinical sites with the largest enrollment at Site 1 (Site 1=

21, Site 2=15 and Site 3=12). All participants were experienced hearing aid users.

8.2. Safety Outcomes

The primary safety endpoint was intended to demonstrate that use of the Earlens Hearing Aid did not

result in a change in residual hearing function. The objective was to identify any change in baseline

hearing after four months of device usage using a four frequency threshold criteria (500, 1000, 2000, and

4000 Hz, referred to as PTA4). A determination of clinically non-significant hearing threshold change was

made if calculated PTA4 hearing change of the subject population was less than 10 dB. After wearing the

Lens for 4 months, no decrease in hearing sensitivity of more than 10 dB was observed. A secondary

safety endpoint assessed any decrease in hearing sensitivity of >10 dB by subject per ear at each test

frequency. After four months of use no subjects exhibited a decrease of >10 dB for either ear at any

frequency. In addition, no serious device or procedure-related adverse events were reported during the

trial. There were 31 adverse events reported in 20 subjects for 22 ears. All but one of the adverse events

were temporary and resolved. One subject report of a ‘fullness’ sensation when wearing the Aid did not

change during the trial and effectiveness outcomes were not impacted. The subject continued use

IFU00021vP

12/19/19

throughout the study period of four months. Table 1 presents the adverse events by type, frequency of

occurrence and resolution status at the conclusion of the study.

8.3. Effectiveness Outcomes

The primary efficacy endpoint was intended to demonstrate device effectiveness by improving speech

recognition using the Northwestern Auditory Test No.6 (NU-6) test of word recognition with the Earlens

Hearing Aid at a speech level of 45 dB HL. The objective was to show that the Earlens Hearing Aid

provides a statistically significant improvement in mean aided word recognition at 30 days post placement

when compared to the baseline unaided condition measured prior to placement. The average baseline

unaided score was 52% and the average aided score was 85% (Figure 7); this improvement was

statistically significant (p<0.0001). A secondary measure of device effectiveness was defined as more

than 10 dB improvement (functional gain) in thresholds over the range of frequencies from 2,000 to

10,000 Hz for aided measured at 30 days post placement when compared to unaided measured prior to

placement. Mean functional gain was 30.5 dB (p<0.0001), indicating that the Earlens Hearing Aid was

able to deliver significant functional gain (Figure 8). Functional gain reached a maximum of 68 dB at 9-10

kHz.

An additional measure of device effectiveness was perceived benefit as measured by the Abbreviated

Profile of Hearing Aid Benefit (APHAB). The average baseline unaided percentage of communication

difficulties was 58% (standard deviation = 16%), the percentage of difficulties decreased to 30%

(standard deviation = 13%) with the subject’s own air conduction hearing aid, and for Earlens it was 29%

-10

100

110

120

100 1,000 10,000

Hearing Level (dB HL)

Frequency (Hz)

Sound-field Threshholds (n = 78 ears)

Aided 30-

day

Baseline

Unaided

100

Unaided baseline Aided 30-day

Percent Correct (%)

Word Recognition (n = 78 ears)

Figure 7: Word Recognition

Figure 8: Sound-field thresholds

Table 1: Adverse events across study period

IFU00021vP

12/19/19

(standard deviation = 14%). 92% of subjects completing the study (35 out of 38) perceived a clinically

significant improvement for Earlens relative to unaided as measured by APHAB.

8.4. Temporary TM Damping

The Lens is designed to remain in place even when the Processor is not worn. When the Processor is

removed (swimming, bathing, sleeping), users may experience TM damping, which would be interpreted

as slight reduction of sound, due to the loading effect of the Lens. The effect on PTA (500 Hz, 1000 Hz

and 2000 Hz) averaged 4 dB, which is immediately reversed when the Lens is removed. When the

Processor is in place, the gain delivered by the Earlens Hearing Aid more than overcomes the TM

damping effect.

8.5. Summary of Extended Study

The safety and effectiveness of the Earlens Hearing Aid was monitored beyond the 4 months of the

Definitive Study. In the Extended Study, 24 subjects (48 ears) opted to continue wearing the Earlens

Hearing Aid after completing the Definitive study. At the conclusion of the Extended Study, 33 ears had at

least 12 months of cumulative Lens wear with no change in unaided air conduction hearing thresholds

under earphones. Of the 24 active subjects in the Extended Wear Study, 11 related AEs were

experienced by 8 subjects in 10 ears. All events were temporary and resolved. Nine of 11 AEs were

related to ear cleaning pre-impression (3 AEs), the impression procedure (4 AEs), or the inspection

process pre-impression (2 AE). Two of the related AEs were attributed to Light Tip fit and both were

resolved after Light Tip modification. One subject continues to report a sensation of fullness.

Driven on the results of the Definitive study, the Earlens Hearing Aid has been shown to be safe and

effective in delivering the full spectrum of amplification from 125 to 10,000Hz.

9. Operating Instructions

9.1. Ear Canal Impression

Before making the ear canal impression using the Earlens Impression System, please read and follow the

precautions and procedures found in the Earlens Impression System Instructions for Use.

9.2. Lens Placement

a. Visually inspect the Lens packaging. DO NOT use if there is any visible damage.

b. Explain to the patient that the ear will be inspected and cleaned, then lubricated with oil (which

may cause some sensations of stuffiness), and the device will be inserted. Instruct the patient to

remain still during the procedure.

c. With the patient in the supine position, use a binocular microscope to inspect the external

auditory canal and the tympanic membrane and determine if there are any contraindications for

Lens placement.

d. Remove all cerumen and epithelial debris from the ear canal, anterior sulcus and tympanic

membrane using the usual office instrumentation and small cotton swabs with mineral oil. If there

is any bleeding or development of contraindications as a result of cleaning of the ear canal, do

not place Lens.

e. Lubricate the ear canal and TM with mineral oil.

f. Read the package label to confirm that the device is for the correct patient and ear (left or right).

On the shipping mold, a right Lens is identified by a red dot and a left by a blue dot.

IFU00021vP

12/19/19

g. The Lens also includes an indicator for a right or left device

which, is dependent on the Lens design. There are two

possible designs you may encounter:

o Grasping Tab left/right of Photodetector (Figure

9): When facing the Photodetector, the Grasping

Tab for a right Lens is located on the right side and

the Grasping Tab for the left Lens is located on the

left side.

o Grasping Tab centered below Photodetector

(Figure 10): When facing the Photodetector, the

Grasping Tab is located below and centered. A right

Lens will have a red dot located on the right side

and a left Lens will have a blue dot located on the

left side.

h. Grasp the Lens at the Grasping Tab (Figure 2) using smooth

alligator forceps.

i. Using alligator forceps, gently advance the Lens through a

thin bladed nasal speculum to the medial region of the ear

canal.

j. Then, using an aural speculum and curved pick, gently

advance the Lens onto the TM and position it such that the

Perimeter Platform is congruent with the anatomical contours of the patient’s anatomical

counterparts. At this point the Umbo platform will be in direct contact with the TM.

k. Once satisfactory positioning is achieved, remove the speculum.

9.3. Lens Removal

a. Explain to the patient that the ear will be inspected and cleaned, lubricated with mineral oil (which

may cause some sensations of stuffiness), and the device will be gently removed. Instruct the

patient to remain still during the procedure.

b. With the patient in the supine position use a binocular microscope to inspect the external auditory

canal and the TM, and determine the position of the device and the location of the grasping tab.

c. Lubricate the ear canal with mineral oil.

d. Using a right angle hook, use the Grasping Tab to capture the device to be removed and slowly

deliver it into the lateral canal. Withdraw the speculum, and use the curved pick to remove the

Lens.

e. Inspect the external auditory canal and the TM.

9.4. Cleaning and Preparing the Lens for Reinsertion

If a Lens is removed the device and canal must be cleaned prior to reinsertion of the device.

a. Remove the Lens per the Lens Removal instructions and carefully place the device in a dish of

mineral oil for soaking.

b. Thoroughly clean the ear canal, anterior sulcus and TM using cotton swabs, mineral oil and

suction as needed. Remove any debris, including epithelial tissue that may have built up in the

anterior sulcus or on the TM.

I. Hydrogen peroxide solution can be used to loosen hard epithelium or cerumen adhered

to the TM or anterior sulcus. Before placement of the Lens ensure all of the hydrogen

peroxide is completely suctioned out, and the applied area is cleaned with mineral oil, to

avoid device contact with the hydrogen peroxide solution.

c. Inspect the umbo of the TM and the area where the Perimeter Platform of the Lens was resting to

ensure it is free of debris or epithelial tissue.

d. After soaking, grasp the Lens at the Grasping Tab using alligator forceps under visual

magnification. Carefully suction any debris remaining from the Perimeter Platform and/or

Photodetector.

Figure 9: Grasping Tab Left/Right of

Photodetector

Figure 10: Grasping Tab Centered Below

Photodetector

IFU00021vP

12/19/19

I. Avoid directly contacting the support springs and Umbo Platform while cleaning the Lens.

II. Holding the Grasping Tab of the Lens with the alligator forceps prevents the Lens from

being suctioned up, dropped to the floor or experiencing undue pressure on the Umbo

Platform. It also aids to control the suction to the Lens.

e. Following the cleaning carefully inspect the Lens to ensure it is free of debris and is not damaged.

I. Replacing a Lens that is not free of debris or is damaged may cause the device to

displace.

f. Proceed with device placement per the instructions outlined in Section 9.2.

9.5. Troubleshooting

The expected life for the Lens is one year. The Lens is expected to exhibit the same failure modes

regardless of the duration of wear. The Lens can become displaced from the tympanic membrane,

blocked by debris or degrade over time. This may cause the sound output of the Earlens Hearing Aid to

cease, become reduced or become intermittent. Perform the following troubleshooting steps to assess

Lens function:

a. Inspect the ear canal and Lens. If the Lens is blocked by debris, carefully clean the ear canal. If

removal or reinsertion is required, follow Lens Removal and Cleaning and Preparing Lens for

Reinsertion instructions above.

b. Inspect the position of the Lens on ear. If the perimeter platform does not appear to be in contact

with the wall of the ear canal, the Lens may be displaced.

I. In the event of displacement of the Lens, remove the device per Lens Removal instructions

and replace following the Cleaning and Preparing Lens for Reinsertion operating

instructions.

c. Inspect the appearance of the Lens on ear. If the Lens appears damaged or abnormal, remove

using the Lens Removal instructions and contact Earlens.

d. If there is a suspected performance issue with the Lens that otherwise appears fine visually (e.g.

significant elevation of system Light Calibration), remove the device per Lens Removal

instructions and replace following the Cleaning and Preparing Lens for Reinsertion operating

instructions. Once Lens is replaced assess if the suspected performance issue is resolved (e.g.

system Light Calibration is no longer elevated).

If after performing the troubleshooting steps listed above, the Lens still does not function, remove it using

the Lens Removal operating instructions and contact Earlens.

9.6. Care & Maintenance

a. Store the Earlens Hearing Aid in a clean, dry location out of direct sunlight.

b. The expected life of the Lens is one year. As for any patient with a hearing assist device, it is

recommended that the patient return annually to their hearing professional(s) to monitor their

audiologic and otologic status.

10. Operating Specifications

• For technical details about the Earlens Light Driven Hearing Aid and compliance to applicable

standards, please consult the Hearing Professional Instructions for Use.

• Certain components of the Earlens Hearing Aid, including the Processor and the Light Tip are

classified as a Type BF applied parts as described in the international standard IEC 60601-1:2005,

Medical Electrical Equipment-Part 1:General Requirements for Basic Safety and Essential

Performance.

• Expected service life of the Earlens Hearing Aid include:

o Processor and Charger- one year

o Light Tip- one year

o Lens- one year

• The Earlens Hearing Aid is designed for continuous use.

IFU00021vP

12/19/19

• The Processor is not designed to prevent the ingress of water.

10.1 Power Requirements

10.2 Operating and Storage Conditions

* If the system is stored at a temperature below room temperature, allow the system to stabilize at room

temperature for a minimum of 1 hour before use.

11. Glossary of Terms

12. Graphic Symbols Contained in Device Labeling

Symbol Description Reference Symbol Description Reference

Refer to instruction

manual/booklet

IEC 60601-

1:2005

ISO 7010-

M002

Temperature limit

ISO 15223-

1:2016,

5.3.7

Separate collection

for electrical and

electronic

equipment

WEEE

Directive

2012/19/EU,

Annex IX

Atmospheric pressure

limitation

ISO 15223-

1:2016,

5.3.9

Keep Dry ISO 15223-

1:2016, 5.3.4 IP21

International

Protection Code

against ingress of

solid foreign objects ≥

12.5mm diameter and

vertically falling water

drops when enclosure

tilted up to 15°

IEC 60601-

1:2005

IEC 60529,

4.2

Caution: Federal

law restricts this

device to sale by or

the order of a

(licensed

healthcare

practitioner)

FDA Final

Rule 81 FR

38911 Serial number

ISO 15223-

1:2016,5.1.

Battery Charger Input

100-240 VAC, 50-60Hz, 0.2A

Battery Charger Output

5.0 VDC, 1.0A

Operating

Conditions

5°C- 40°C

15-93% humidity

700 – 1060 hPa

Storage

Conditions and

Temperature

Limit*

-20ºC to 50ºC

Maximum relative humidity of

93% non-condensing.

Use conditions

Avoid high temperatures

and sustained exposure to

direct sunlight.

Frequency

range

100Hz to 10,000Hz

Tympanic Membrane

Lens

Tympanic Lens

ELF

Earlens Fitting Software

EAS

Electronic Article Surveillance

Adverse Event

IFU00021vP

12/19/19

Humidity limitation ISO 15223-

1:2016, 5.3.8 Caution

ISO 15223-

1:2016,

5.4.4

Class 1 laser

product

IEC 60825-

1:2007, 5.2 MR unsafe ASTM

F2503-13

Batch code ISO 15223-

1:2016, 5.1.5

FCC Part 18

Declaration of

Conformity

FCC

Guidelines

for

Labeling,

Part 15 and

Part 18,

2014

Catalog number ISO 15223-

1:2016, 5.1.6 Non-ionizing radiation

IEC 60601-

1-2:2007

IEC 60417-

5140

(2003-04)

Date of

manufacture

ISO 15223-

1:2016, 5.1.3 Type BF applied part

IEC 60601-

1:2005

IEC 60417-

5333

13. Laser Certification

The Earlens Light-Driven Hearing Aid complies with 21CFR 1040.10 and 1040.11.

Manufacturer (Ref. ISO 15223-1:2016, 5.1.1):

Earlens Corporation, Inc.

4045A Campbell Ave.

Menlo Park, CA 94025

Patent Protected/Pending: www.earlens.com/patents

Apple, the logo, AirPlay, iPhone, iPad, iPod are trademarks of Apple Inc., registered in the U.S. and

other countries.

earlens Light Operating instructions

earlens Light Operating instructions

earlens Light Operating instructions

Related papers

Other documents